长沙招聘

KEY ACCOUNTABILITIES：

·               Draft and update the related quality procedures and perform the quality training per CFDA medical device GSP regulation.

·               Be the role of the training coordinator to assign the training in system and follow up the completion of the training; perform the onsite process/procedure training when required.

·               Work with RA to prepare and release the artwork of Chinese labels for imported products.

·               Coordination of complaint intake and evaluation, both locally and in cooperation with manufacturing plants for investigations.

·               Responsible for Adverse Event reporting activities per local regulation.

·               Perform the complaint reporting training when required.

·               Be responsible for the field action or product recall internal coordination and reporting.

·               Support and oversee the warehouse for incoming medical devices (direct sale business) prior to their release to the Chinese market.

·               Identify the current operation process and lead the improvement project.

·               Other tasks assigned by manager.

REQUIREMENTS：

Education Requirement: University graduate with background related to medical devices, medicine science, chemistry or pharmacy etc.

·               Industry experiences: A minimum of three years in the medical device or pharmaceutical industry.

·               Position experiences: experience in GSP. Preference manufacturing site and GMP working experience and ISO 13485.

·               Language Skills: English level is at or above CET-6 , skilled in oral and written English.

·               Computer Skills: Familiar with the MS software, knowledge of Excel for the data analysis, power point for the monthly presentation, SAP experiences is preferred

·               Other Special requirement: Strong in skills for communication with different parties, independent problem-solving ability, self-driving, active to learning and manage change etc

WORKING RELATIONSHIPS

Internal contacts:

Marketing Team, Sales Team, Supply Chain Team, RA Team

External contacts:

HA, Suppliers and related associations, custome

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